BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS 030-223

    MDR report key: 65448 · Received January 24, 1997

    Report

    Report Number
    1316542-1997-00124
    Event Type
    Injury
    Date Received
    January 24, 1997
    Date of Event
    July 2, 1996
    Report Date
    January 24, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS CUT AND CAPPED DUE TO A REPORT OF THE EPICARDIAL PATCH LEAD CAUSED NOISE AND OVERSENSING. THE ASSOCIATED LEAD AND ADAPTOR WERE CUT AND CAPPED FOR THE SAME REASON. NO FURTHER INJURY OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS 030-223 Implant PERMANENT IMPLANTABLE PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 030-223 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 030-223 58589B,| 030-308 1624.